The new in vitro diagnostics regulation is here. Register for our webinar to understand the legislation and learn how diagnostic assay providers can address the challenges IVDR brings.
This webinar was hosted on the 20th of February 2020, 4pm (16:00) Central European Time.
A recording is available on this webpage.
Get a thorough introduction to IVDR, the new legislation that impacts European In Vitro Diagnostics. Learn about the MDx requirements, role of notified bodies, and the legislation as such.
Learn about the implications and the changes from IVDD to IVDR. We'll review conformity assessment and scrutiny, how IVDR impacts your molecular diagnostic kits, the impact on assay lifecycle processes, and more.
At UgenTec, we've worked closely with COCIR and other regulatory instances to ensure our strategy simplifies the way IVD companies bring assays to market in this new context - supporting Performance Evaluation, gathering clinical evidence.
"Well over 500,000 medical devices currently on the EU market will have to be recertified under MDR & IVDR."
Nele Ooms has 15 years of experience in various quality and regulatory affairs roles in the pharmaceutical and medical device industry. She started her career at Johnson & Johnson in Janssen R&D QA. Currently she is responsible for quality and regulatory affairs at UgenTec, a company that develops software for molecular laboratories.